1. Field of the Invention
This invention relates to procedures and devices for treating stress urinary incontinence (SUI), and more particularly relates to the use of implants for treating SUI and devices for deploying such implants.
2. Description of the Prior Art
Stress urinary incontinence (SUI) is a female medical condition associated with the weakening of the pelvic muscles and/or connective tissues-which support the urethra in its proper position. As a result of this condition, involuntary urine leakage occurs from simple physical activity, such as running or jumping, and even coughing or sneezing, as the urethra is not properly supported and does not remain fully closed during such activity.
A widely accepted medical procedure to correct SUI is the insertion of a trans-vaginal tape (TVT). The TVT is an elongated polypropylene mesh tape which is surgically implanted in the pelvic tissue to partially surround and provide support for the urethra. A conventional TVT is disclosed in U.S. Pat. No. 5,899,909, which issued to Jan Claren et al.
The conventional procedure for treating SUI using a TVT is to surgically insert one end of the mesh tape through an incision in the vaginal wall on one lateral side of the urethra using an elongated curved needle, through the pelvic tissue behind the pubic bone, and exiting through an incision made in the abdominal wall. The procedure is repeated for the other end of the mesh tape, this time on the other lateral side of the urethra, with the needle exiting through a second incision made in the abdominal wall of the patient. After the mesh tape is tightened for proper support of the urethra, its free ends extending outside of the abdominal wall are trimmed.
One of the disadvantages of trans-vaginal tapes is that they require two separate, albeit minimal, incisions made through the abdominal wall through which exit the curved needles to which the mesh tape ends attach. Although this involves a minimally invasive surgical procedure, it is still considered major surgery by patients. Also, the external incisions increase the risk of postoperative infection to at least a small degree.
Trans-vaginal slings are also conventionally used for treating SUI. Current slings require abdominal incisions and use anchors, e.g., staples, to implant the sling. Furthermore, conventional trans-vaginal slings further require anchoring the sling to the patient's pubic bone and/or abdomen, thus requiring multiple incisions, stitching and the like throughout the patient's pelvic region. This surgical procedure often requires general or spinal anesthesia to be administered to the patient. Additionally, there is usually a prolonged recovery associated with this procedure, with a concomitant reduction in the patient's ambulatory functions. A vaginal sling, for example, is disclosed in U.S. Pat. No. 6,039,686, which issued to S. Robert Kovac.